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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01616732
Registration number
NCT01616732
Ethics application status
Date submitted
8/06/2012
Date registered
12/06/2012
Date last updated
6/06/2016
Titles & IDs
Public title
Testosterone and Weight Loss
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Scientific title
Effect of Testosterone and Diet on Weight
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Secondary ID [1]
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04495
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity in Men
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Testosterone
Treatment: Drugs - placebo
Active Comparator: testosterone - against placebo
Placebo Comparator: placebo -
Treatment: Drugs: Testosterone
TU im
Treatment: Drugs: placebo
placebo im
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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weight
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Assessment method [1]
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Timepoint [1]
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12 months
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Eligibility
Key inclusion criteria
- BMI >30
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
- contraindications to testosterone therapy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2015
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Sample size
Target
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Accrual to date
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Final
100
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Austin Health - Heidelberg
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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Funding & Sponsors
Primary sponsor type
Other
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Name
Austin Health
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The investigators hypothesise that testosterone therapy will synergize with dietary
intervention to achieve weight loss. Obese men will receive diet, and be randomised to either
testosterone therapy or placebo. Primary outcomes will be weight and body composition.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01616732
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01616732
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